NCT02390128

Brief Summary

This is an observational study in pregnant mothers and their newborn babies. The rationale of the study is to examine early markers of the effects of iodine insufficiency during pregnancy on thyroid stimulating hormone (TSH) and thyroglobulin in mother and baby.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
697

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 17, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Last Updated

March 17, 2015

Status Verified

March 1, 2015

Enrollment Period

2 years

First QC Date

November 30, 2014

Last Update Submit

March 16, 2015

Conditions

Thyroid Function

Keywords

iodinethyroidTSHpregnancynutritiondiet

Outcome Measures

Primary Outcomes (2)

  • thyroid function of mothers (measurement of TSH and Tg)

    measurement of TSH and Tg

    up to 38 week gestation

  • thyroid function of infant (routine TSH measurement)

    routine TSH measurement

    Day 4 of life

Secondary Outcomes (3)

  • Iodine status of mothers (iodine intake and excretion)

    up to 38 week gestation

  • Iodine status of infant (iodine intake and excretion)

    Day 4 of life

  • Iodine level in hair and breastmilk

    after birth

Study Arms (1)

mothers and babies

pregnant mothers (UK resident) and their babies (observational, not an intervention)

Other: observational only

Interventions

observational onlyOTHER
mothers and babies

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women and their newborn baby

You may qualify if:

  • Healthy pregnant women
  • Able to read, write and speak in English
  • Attending a Greater Glasgow and Clyde maternity unit

You may not qualify if:

  • Abnormal pregnancies.
  • Mothers with known thyroid disorders.
  • Preterm infants (born before 37 completed weeks).
  • Multiple births.
  • Infants with postnatal problems such as infection or malformation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NHS GGC Community midwifery units

Glasgow, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

urine, blood, hair, breastmilk

MeSH Terms

Conditions

Thyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Officials

  • Filiz Cizmecioglu

    University of Glasgow

    PRINCIPAL INVESTIGATOR

  • Emilie Combet

    University of Glasgow

    STUDY DIRECTOR

  • Jeremy Jones

    University of Glasgow

    PRINCIPAL INVESTIGATOR

  • Malcolm Donaldson

    University of Glasgow

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emilie Combet, PhD

CONTACT

+441412018527emilie.combetaspray@glasgow.ac.uk

Jeremy Jones

CONTACT

jeremy.jones@glasgow.ac.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

November 30, 2014

First Posted

March 17, 2015

Study Start

January 1, 2015

Primary Completion

January 1, 2017

Last Updated

March 17, 2015

Record last verified: 2015-03

Locations

GB(1)